An enclosed PEEK cell is used to minimise any potential contaminates in the machining of polyether ether keytone for surgical implants. The enclosure has positive pressure, is equipped with a HAAS VF-3SS 5-axis mill, an ultrasonic cleaning line, a finishing area for deburring, and a comparator. As it is a clean room, operators are gowned and gloved and material is received and stored within the cell. All PEEK cell equipment and processes are validated for IQ, OQ, PQ.

Cleaning Validation

  • Cytotoxicity Test Performed Quarterly
  • Routinely Score 0 to 1
  • Bioburden Tested

Equipment

  • 5-Axis Mill
  • Ultrasonic Cleaning
  • Finishing Area for Deburring
  • Material Storage
  • Saw

Cell

  • Particulate Free Enclosure
  • Positive Pressure
  • Operators are Gowned and Gloved
IMG_6399
PM 2013_16 Implantable Peek Implants